Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002

K-Number: K902692 · 1990-09-13

ApplicantDiagnostic Ultrasound Corp.
Decision Date1990-09-13
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Ultrasound Corp.. It received FDA 510(k) clearance on 1990-09-13 under 510(k) number K902692. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002?

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 is a medical device that received FDA 510(k) clearance on 1990-09-13. The listed applicant is Diagnostic Ultrasound Corp.. The 510(k) number is K902692.

When did DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 received FDA 510(k) clearance on 1990-09-13, under 510(k) number K902692.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002?

The FDA 510(k) record lists Diagnostic Ultrasound Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002?

The FDA product code for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 is FAP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Ultrasound Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030763DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEMK022153BLADDERSCAN BVI 6100K982568BLADDERMANAGER PCI 5000 MODEL 1002K963585BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000K955840BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000K955942BLADDERSCAN BVI 5000

View all 16 devices →

Related Devices (Code: FAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑